欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ritemvia
适用类别Human
治疗领域Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Wegener Granulomatosis
通用名/非专利名称rituximab
活性成分rituximab
产品号EMEA/H/C/004725
患者安全信息No
许可状态Withdrawn
ATC编码L01XC02
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2017/07/13
上市许可开发者/申请人/持有人Celltrion Healthcare Hungary Kft.
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2017/05/18
欧盟委员会决定日期2020/10/09
修订号8
治疗适应症Ritemvia is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy. Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Ritemvia monotherapy is indicated for treatment of patients with stage III, IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Granulomatosis with polyangiitis and microscopic polyangiitis. Ritemvia, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
适用物种
兽用药物ATC编码
首次发布日期2018/05/17
最后更新日期2021/08/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/ritemvia-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ritemvia
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